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(RTTNews) - Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on genetically driven neuromuscular diseases, announced two major updates today: new long-term cardiopulmonary data from its DELIVER trial in Duchenne muscular dystrophy (DMD) and the initiation of Phase 3 HARMONIA trial in myotonic dystrophy type 1 (DM1).

Positive DELIVER Results in DMD

New analyses from the ongoing Phase 1/2 DELIVER study of z-rostudirsen, also known as DYNE-251, in Duchenne muscular dystrophy showed sustained improvement in heart and lung function out to 24 months, compared to the expected decline seen in natural history data. Improvements were observed in forced vital capacity (lung function), circumferential strain (early cardiac performance signal), and left ventricular ejection fraction.

These findings build on previously reported muscle function benefits and reinforce the potential of Dyne's FORCE platform to deliver therapeutics broadly across muscle systems, including the heart and diaphragm.

Dyne plans to submit a Biologics License Application (BLA) for U.S. Accelerated Approval in Q2 2026, with a potential U.S. launch in Q1 2027, assuming Priority Review and FDA approval is received on the anticipated timeline. This launch would be under the FDA's Accelerated Approval pathway based on Phase 1/2 data, while a global confirmatory Phase 3 clinical trial is also expected in Q2 2026.

Initiation of Phase 3 HARMONIA Trial in DM1

Dyne also announced the start of the HARMONIA Phase 3 trial of z-basivarsen, also known as DYNE-101, in DM1. The global, randomized, placebo-controlled study will enroll about 150 participants and run for 48 weeks, with the five times sit-to-stand (5x STS) test as the primary endpoint.

Secondary measures include muscle function, CNS manifestations, and patient-reported outcomes. The trial design has been aligned with the FDA and is intended to serve as a confirmatory study for traditional approval in the U.S. and to support ex-U.S. filings.

Dyne will present these new cardiopulmonary results and provide updates on the HARMONIA trial at the Muscular Dystrophy Association (MDA) conference on March 11, 2026.

DYN has traded between $6.38 and $25.00 over the past year. The stock closed Friday's (March 6, 2026) trading at $14.86, down 2.24%. During overnight trading session, the stock is up $14.58, down 1.88%.

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